NCT07456410

Development and Validation of Psycho-Social Program (PSP)

Development and Validation of Psycho-Social Program (PSP) for Mental Health Problems Among Patients With Type 2 Diabetes Mellitus (T2DM): A Randomised Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Government College University Faisalabad · Academic / Other
• Sex: All
• Age: 30 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The study aims to determine the effectiveness of a structured psycho-social program (PSP) in improving mental health outcomes among patients with Type 2 diabetes mellitus (T2DM). The intervention is designed to reduce symptoms of depression, anxiety, and diabetes-related distress (DD) by addressing maladaptive thoughts, emotional responses, and coping behaviors associated with chronic illness management. Through structured sessions incorporating cognitive restructuring, stress management techniques, behavioral activation, and adaptive coping strategies, participants will learn to manage emotional distress more effectively while improving treatment adherence and daily functioning. The intervention is expected to enhance psychological well-being, promote healthier coping mechanisms, and support better overall adjustment to living with T2DM.

Detailed description

This study aims to evaluate the effectiveness of a structured psycho-social program (PSP) in improving mental health outcomes among patients with Type 2 diabetes mellitus (T2DM.) A total of 80 participants, aged 30-40 years, will be recruited from academic and clinical settings in Faisalabad, Pakistan, using purposive sampling. Participants will be randomly assigned to two groups: the intervention group (n=40) will receive 6-8 sessions of the psycho-social program targeting depression, anxiety, diabetes-related distress, medication adherence and quality of life, while the control group (n=40) will receive standard care without the intervention. Participants with mild-to-moderate psychological distress will be included, whereas those with severe psychiatric conditions, co-morbidities, or under psychiatric medication will be excluded. Pre- and post-intervention assessments using validated instruments will measure changes in mental health outcomes, coping skills, and overall quality of life. The study is expected to show that the psycho-social program reduces psychological distress, enhances adaptive coping, and improves well-being, providing evidence-based guidance for mental health support in Type 2 diabetes patients.

Conditions

• Mental Health Issue
• Depression
• Diabetes Distress
• Quality of Life
• Medication Adherence

Interventions

Type	Name	Description
BEHAVIORAL	Psycho-Social Program	Participants in the intervention group will receive 6-8 sessions of psycho-social program (PSP) designed to improve mental health outcomes in patients with Type 2 diabetes. The session-wise agenda includes: Session 1 - Psychoeducation about diabetes and mental health; Session 2 - Behavioral Activation to increase engagement in health-promoting activities; Session 3 - Cognitive Conceptualization and Restructuring to identify and challenge negative thoughts; Session 4 - Stress Management; Session 5 - Time and Lifestyle Management; Session 6 - Problem-Solving Skills; and Session 7 - Relapse Prevention and Follow-up Planning to maintain progress and adaptive coping

Timeline

• Start date: 2026-03-25
• Primary completion: 2026-07-28
• Completion: 2026-08-28
• First posted: 2026-03-06
• Last updated: 2026-03-06

Locations

1 site across 1 country: Pakistan